Violation of "Subpart D - Equipment-211.67 Equipment cleaning and maintenance."

1. Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)).

Violation of "Subpart D - Equipment-211.67 Equipment cleaning and maintenance."

Observations

The firm manufactures numerous over-the-counter (OTC) drug products in various dosage forms on non-dedicated equipment including blenders, and tablet presses.

FDA investigators observed that the cleaning validation studies for many critical, non-dedicated equipment with direct drug product contact surfaces were incomplete.

During the inspection, the firm was unable to provide adequate justification that current cleaning procedures adequately remove drug residues and prevent cross-contamination.

With this firm’s cleaning procedures lacked adequate specificity and detail to be performed consistently and be validated.

For example, standard operating procedure (SOP) MF- 22 “Procedure for Cleaning ” Section 7.3.9 contained instructions to are an example of product contact equipment that is extremely difficult to clean and is therefore usually dedicated to a specific drug product.

The firm did not have scientific data that visibly clean XYZ does not result in the carryover of drug residues from one drug product to another.

Additionally, cleaning to remove only visual residue is inadequate. Non-visible residues, including those from the cleaning process itself, must also be adequately removed. The FDA suggested that firm must have adequate and validated cleaning procedures.

This is a repeat observation from the 2020 inspection and was a discussion item during the August 13, 2020, regulatory meeting.

In the Firm's response, firm stated that the firm will review and revise cleaning procedures, update cleaning validation protocols, and contract a third party to assist with cleaning validation.

The response was said to be inadequate because it did not consider the impact that the firm's deficient cleaning practices for non-dedicated equipment may have had on drug products that remain on the U.S. market.

Additionally, firm stated that upon the resumption of manufacturing, the firm would implement interim equipment cleaning validation protocols. However, the firm did not provide sufficient details about such protocols.

Committed but not done.

All above-caused Warning Letter to the firm.