Renu Laboratories, LLC
Form 483 issued July 27, 2022 · Warminster, Pennsylvania
- Inspection
- Jul 19 – Jul 27, 2022
- Investigator
- Rachael O. Oyewole
- Observations
- 7
- Pages
- 5
- FEI number
- 3003263206
In short: On July 27, 2022, FDA issued a Form 483 with 7 observations to Renu Laboratories, LLC in Warminster, Pennsylvania (FEI 3003263206) after an inspection that ran Jul 19 – Jul 27, 2022. The investigator was Rachael O. Oyewole. Most observations concern quality system and facilities & equipment.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
Procedures describing the handling of written and oral complaints related to drug products are…
- 02
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would…
- 03
The identity of each component of a drug product is not verified by conducting at least…
- 04
Time limits are not established when appropriate for the completion of each production phase to assure…
This inspection in context
Rachael O. Oyewole
10 documents · 2020–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmRenu Laboratories, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.198(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Renu Laboratories, LLC?
FDA listed 7 observations on this Form 483, mostly about quality system, facilities & equipment and materials. The opening words of each observation are shown on this page.
Who inspected Renu Laboratories, LLC?
Rachael O. Oyewole is named on this Form 483, for the inspection of Jul 19 – Jul 27, 2022. Each investigator has a profile showing what they cite most.
When was Renu Laboratories, LLC inspected by FDA?
The inspection ran Jul 19 – Jul 27, 2022, and the Form 483 is dated July 27, 2022.
How do I get the full Form 483 for Renu Laboratories, LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.