FDA 483 - h & p industries, inc. - July 17, 2009

The FDA Form 483 document details numerous violations observed during an inspection. The facility's quality control unit lacks written and followed procedures, and GMP training frequency is insufficient. Investigations into Out of Specification (OOS) batches, specifically Hemorrhoidal Suppositories with Phenylephrine, did not extend to other products containing Phenylephrine (e.g., Hemorrhoidal Cream and Ointment). Reprocessing was performed without Quality Control (QC) unit approval for Infant and/or Adult Glycerine Suppositories.

Rejected in-process materials, such as Glycerine Suppository lot #9C150B, were not adequately identified, controlled, or quarantined. Several batches of Hemorrhoidal Suppository with Phenylephrine (e.g., 8K100, 8K151, 8L200) were released despite failing to meet Phenylephrine specifications. Deviations from specifications were not justified; OOS investigations for lots 8K100 and 8K151 were not documented, and nine out of eleven OOS investigations lacked required Quality Unit Manager signatures.

Supplier analysis reports were accepted without establishing reliability through validation. The finished product reject storage area was not properly designated or separated. Equipment design was inappropriate for intended use and cleaning; examples include a plastic bucket for product transfer, and the Infant and Adult Glycerin Suppository filling line's scraper, pins, and ejector bin, which