No, this Warning Letter is NOT for the company you think - OR in 'that country'

Sometimes the US-FDA finds problems 'close to the Heartland'

Please make time to read this letter completely when you get to the link at the end. The way it is labeled at the top will confuse you (as I said it's not "that company") and the location is not somewhere in Asia. It's in the US Southwest. These are only some excerpts. Only the FDA observations are in bold in the original letter, dated last week.

CGMP Violations

 1.    Your firm does not have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient and absence of objectionable microorganisms, prior to release (21 CFR 211.165(a) and (b)).

 During the inspection, you stated that you do not test any of the topical antiseptic drug products that you manufacture. For example, you distributed Diabecline lot 61111 on September 6 and September 29, 2016, and Tetracycline-ABC lot 511110 on October 13, 2016, without testing. Specifically, you did not test these lots for chemical attributes, including identity and strength of each active ingredient. 

 In addition, your firm lacked testing for microbial attributes, including absence of objectionable microorganisms, or sterility, where appropriate. ,,,

[Labs are often a topic but don't bother looking for a computer system citation here. And, frankly, the lack of computers is 'the least of their problems.']

2.    Your firm failed to use equipment constructed to ensure surfaces that contact components, in-process materials, or drug products are not reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirement (21 CFR 211.65(a)).

[Somehow I don't think the following is exactly what 21 CFR 211.65(a) was written to address but see if you think it fits.]

 Our investigator observed bulk drug products stored in repurposed household containers, such as bottles for plastic soft drinks, juice, milk, and cleaning agent. For example, we found that you used a repurposed home cleaning agent spray bottle to store bulk StaphWash. This home cleaning agent contains ingredients such as sodium percarbonate and hydrogen peroxide.

3.    Your firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit (21 CFR 211.22(d)).

 During the inspection, we found that your firm lacked critical procedures to ensure a functional quality unit including, but not limited to, procedures for establishing specifications, review and approval of investigations, complaint handling, and change management.

[Remember that this site is not ex-US. Something to remember when you read other letters.]

For example, you stated that you do not have specifications for your drug products because you frequently alter formulations during manufacturing. Given your poor manufacturing practices, there is substantial potential for production of inconsistent and poor-quality drug products. It is imperative that drug products be consistently manufactured to ensure each batch meets appropriate quality standards and specifications.....

5.    Your firm failed to establish written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).

 You have not specified or validated manufacturing processes to ensure reproducible batch quality. For example, your procedures for filling and hold times do not include defined process parameters such as mixing times, blending speeds, and bulk hold times. In addition, our investigator noted that you use a household kitchen blender to mix ingredients. [While a down-home approach, there are some compliance questions. Although, in fairness, have you ever used baking a cake as an example of a process?]

 Our findings demonstrate a lack of understanding of the basic elements of a compliant manufacturing operation, [Who says the FDA tends to use hyperbole? This seems rather restrained.] such as suitable facilities and equipment, trained personnel, appropriate components, a well-defined process, and written procedures. These and other elements supporting process validation are outlined in FDA’s guidance document, Process Validation: General Principles and Practices, available at https://www.fda.gov/downloads/drugs/guidances/ucm070336.pdf.

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Let's call it a letter, shall we, since you have probably seen enough? I strongly recommend that you read the observations (6 in total), as well as the rest of the letter about Unapproved New Drug Violations and two more areas.

You may find the full letter under this reference or (hopefully) by clicking it as a link: Ref: 2017-DAL-WL–20 There is a lot to unpack. (If you choose to print it to pdf or to paper for later reading, it will be six pages long.) My point is that while the FDA inspectors in Asia are generating a lot of attention, there is still a lot to do in other places that are a much shorter trip.