Drug factory · FDA FEI 3004161147

Sharp Packaging Services, LLC

7451 Keebler Way, Allentown, PA, United States

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.

Jan 28, 2022 inspection

• Actual vs. theoretical yields not determined 21 CFR 211.103
  Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate phase of packaging of the drug product.
• Control procedures to monitor and validate performance 21 CFR 211.110(a)
  Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
• Destruction of excess labels with lot numbers 21 CFR 211.125(d)
  Excess labeling bearing lot or control numbers is not destroyed.
• Packaging line inspection before use 21 CFR 211.130(e)
  Inspection of the packaging and labeling facilities immediately before use is not done to assure that all drug products have been removed from previous operations.
• Written warehousing procedures established/followed 21 CFR 211.142
  Procedures describing the warehousing of drug products are not established and followed.
• Accurate reproduction 21 CFR 211.188(a)
  The batch production and control records are deficient in that they are not an accurate reproduction of the appropriate master production or control record and checked for accuracy, dated, and signed.
• Written record of investigation incomplete 21 CFR 211.192
  Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up.
• Complaint Investigation/Follow-Up Findings 21 CFR 211.198(b)(2)
  Complaint records are deficient in that they do not include the findings of the investigation and follow-up.
• Approve or reject components, products 21 CFR 211.22(a)
  The quality control unit lacks the responsibility and authority to approve all components, labeling and drug products.
• Procedures not in writing, fully followed 21 CFR 211.22(d)
  The responsibilities and procedures applicable to the quality control unit are not fully followed.
• Buildings of Suitable Size, Construction, Location 21 CFR 211.42(a)
  Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable construction and location to facilitate cleaning, maintenance, and proper operations.
• Equipment Design, Size and Location 21 CFR 211.63
  Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its cleaning and maintenance.
• Backup file not maintained 21 CFR 211.68(b)
  Failure to maintain a backup file of data entered into the computer or related system.

Apr 24, 2019 inspection

• Component Test Records 21 CFR 211.184(b)
  The component records do not include the results of tests or examinations performed and the conclusions derived from tests or examinations performed.

Registered with FDA for: label; manufacture; pack; relabel; repack; sterilize.