Inspection Record

L. Perrigo Co — FDA 483 Findings

US FDAInspected 2015-07-11Published 2024-01-17 5 findingsLaboratory and QC controlsContamination controlProcess validationEquipment and facility

View the regulator's official source The source document is always the basis for judgement.

Findings

1Laboratory and QC controls

Drug products failing to meet established quality control criteria are not rejected.

2Contamination control

Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not followed.

3Process validation

Written production and process control procedures are not followed in the execution of production and process control functions.

4Equipment and facility

Written records ofmajor equipment cleaning, maintenance, and use are not included in individual equipment logs.

5Equipment and facility

Written procedures are not followed for the cleaning and maintenance ofequipment, including utensils, used in the manufacture, processing, packing or holding ofa drug product.

About this record

Extracted automatically from the document US FDA published on 2024-01-17. The source is available at the link above.

This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.

Translation and classification are automated and may differ in nuance from the source.

Other records for this company

2015-07-23 · US FDA · 8 findings2015-07-10 · US FDA · 19 findings2015-07-11 · US FDA · 7 findings2015-07-10 · US FDA · 10 findings2015-07-10 · US FDA · 3 findings
L. Perrigo Co findings history — including this company's other documents US FDA documents, 2024 Go to Findings search