Geri-Care Pharmaceuticals, Corp.
Form 483 issued May 5, 2025 · Lakewood, New Jersey
- Inspection
- Apr 24 – May 5, 2025
- Investigators
- Damaris Y. Hernandez· Pamela N. Agaba
- Observations
- 5
- Pages
- 22
- FEI number
- 2435388
In short: On May 5, 2025, FDA issued a Form 483 with 5 observations to Geri-Care Pharmaceuticals, Corp. in Lakewood, New Jersey (FEI 2435388) after an inspection that ran Apr 24 – May 5, 2025. The investigators were Damaris Y. Hernandez and Pamela N. Agaba. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Laboratory controls and quality system account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
The accuracy, sensitivity and specificity of test methods…
- 04
Specific identification tests are not conducted on components that have been accepted based on the…
This inspection in context
Damaris Y. Hernandez
17 documents · 2022–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Florida.
The firmGeri-Care Pharmaceuticals, Corp. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Geri-Care Pharmaceuticals, Corp.?
FDA listed 5 observations on this Form 483, mostly about laboratory controls, quality system and materials. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Geri-Care Pharmaceuticals, Corp.?
Damaris Y. Hernandez and Pamela N. Agaba are named on this Form 483, for the inspection of Apr 24 – May 5, 2025. Each investigator has a profile showing what they cite most.
When was Geri-Care Pharmaceuticals, Corp. inspected by FDA?
The inspection ran Apr 24 – May 5, 2025, and the Form 483 is dated May 5, 2025.
How do I get the full Form 483 for Geri-Care Pharmaceuticals, Corp.?
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.