Drug factory · FDA FEI 3004765103

Blenheim Pharmacal, Inc.

North Blenheim, New York, United States

Matched to FDA's records by company name, because this plant's registration on the label has expired.

What it does, for whom

FDA inspection history

What inspectors wrote down

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Jun 19, 2013 inspection

• Absence of Written Procedures 21 CFR 211.100(a)
  There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
• SOPs not followed / documented 21 CFR 211.100(b)
  Written production and process control procedures are not followed in the execution of production and process control functions.
• Storage under appropriate conditions 21 CFR 211.142(b)
  Drug products are not stored under appropriate conditions of temperature and humidity so that their identity, strength, quality, and purity are not affected.

May 18, 2012 inspection

• Procedures are written, and followed 21 CFR 211.130
  Procedures designed to assure that correct labels are used for drug products are not followed.
• Packaging line inspection before use 21 CFR 211.130(e)
  Inspection of the packaging facilities immediately before use is not done to assure that all drug products have been removed from previous operations.

Jun 17, 2011 inspection

• Written procedures not followed 21 CFR 211.122(a)
  Written procedures for the handling of packaging and labeling materials are not followed.
• Records of disposition of rejected material 21 CFR 211.184(e)
  Records do not include the disposition of rejected drug product containers.

Jul 28, 2010 inspection

• Procedures are written, and followed 21 CFR 211.130
  Procedures designed to assure that correct labels are used for drug products are not followed.