FDA WARNING_LETTER - Penn Pharmaceuticals Services Ltd. - February 07, 2013

On February 4-7, 2013, an FDA inspection of Penn Pharmaceuticals Services, Ltd. in Gwent, Wales, revealed that their synthetic bone filler material, β-TCP, is an adulterated device under 21 U.S.C. § 351(h) because manufacturing, packing, storage, or installation methods do not conform to cGMP requirements of the Quality System (QS) regulation (21 CFR Part 820).

Violations include: 1. Failure to establish and maintain procedures for monitoring and control of process parameters for validated processes (21 CFR 820.75(b)), evidenced by an undocumented deviation in Batch # (b)(4) and insufficient confirmation of corrective actions. 2. Failure to review and evaluate processes and perform revalidation when changes or deviations occur (21 CFR 820.75(c)), shown by an uninvestigated seal delamination during performance qualification and lack of revalidation documentation. 3. Failure to establish and maintain procedures for investigating nonconformities (21 CFR 820.100(a)(2)), as seen in an uninvestigated out-of-specification incident for DR-1063. 4. Failure to establish and maintain data describing specified requirements for purchased products and services (21 CFR 820.50(b)), specifically lacking purchasing documents with