Ciao, Bella and "Arrivederci" - but here's your Warning Letter anyway!

And the US "FDA placed your firm on Import Alert 66-40 on November 27, 2017"

This warning letter, issued to an Italian firm on November 29, 2017, is spare and direct. And it begins by referring to an amazingly refreshing reply from the company. This was a quick turnaround process - inspection ended 23 JUN 2017 and the reply came back on 06 July. The warning letter was issued in less than 5 months after the reply. Perhaps we should let the letter speak mostly for itself. All emphasis is the editor, save for the bold defining the numbered deficiencies.

Let's begin with the introduction

We reviewed your July 6, 2017, response in detail. You did not commit to any corrective actions regarding the CGMP violations observed during the inspection and stated that you “will not be able for the time being to comply with USA Good Manufacturing Practices for OTC pharmaceuticals,” and “will therefore immediately cease to sell and ship to USA.”

[ A very honest and straightforward response, don't you agree? ]

During our inspection, our investigator observed specific violations including, but not limited to, the following.

 1. Your firm failed to 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, prior to release (21 CFR 211.165(a)).

 Your firm failed to test your drug products for identity and strength of active ingredients prior to release and distribution.

[And #1 should lead directly to #2.]

 2. Your firm failed to ensure the identity of components sourced from various suppliers, including your active ingredients (21 CFR 211.84(d)(1) and (2)).

 You failed to test incoming active pharmaceutical ingredients (API) you use in manufacturing drug products to determine their identity, purity, strength, or other appropriate specifications. Instead, your firm released API based on certificates of analysis from your supplier without establishing the reliability of the supplier’s analysis through appropriate validation.

3. 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 validated the manufacturing processes for your drug products. You lack assurance that your manufacturing processes result in batch uniformity, integrity, and consistent drug quality.

 [Validation is very difficult without procedures and process control.]

4. Your firm failed to ensure that its drug product bore an expiration date that was supported by appropriate stability testing (21 CFR 211.137(a)).

 You stated to our investigator that you had no written stability program to support the (b)(4) expiration date of your over-the-counter (OTC) drug product.

[If it wasn't written down, it's only a rumor ... of stability.]

CGMP Consultant Recommended

If your firm resumes manufacturing drugs for the United States market, we strongly recommend engaging a consultant, qualified as set forth in 21 CFR 211.34, to assist your firm in meeting CGMP requirements. Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for fully resolving all deficiencies and ensuring ongoing CGMP compliance.

 [A very big "IF," I think you will agree.]

Conclusion

Violations cited in this letter are not intended as an all-inclusive list. You are responsible for investigating these violations, for determining the causes, for preventing their recurrence, and for preventing other violations.

FDA placed your firm on Import Alert 66-40 on November 27, 2017.

[Note that alert was effective 2 days before the letter was signed.]

Until you correct all violations completely and we confirm your compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug manufacturer.

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To read the full letter, either click on this link Warning Letter 320-18-11 or search either by the reference or ucm592712, As I observed at the top, this is a refreshingly direct and honest response. Then again, if you use their products, you may have the same reaction to this as seen in the morning Dilbert today. Your comments and observations are always welcome.