APL HEALTHCARE LIMITED
Form 483 issued December 17, 2025 · Menakuru, India
- Inspection
- Dec 8 – Dec 17, 2025
- Investigators
- Guerlain Ulysse· Rafeeq Habeeb
- Observations
- 5
- Pages
- 13
- FEI number
- 3011895410
In short: On December 17, 2025, FDA issued a Form 483 with 5 observations to APL HEALTHCARE LIMITED in Menakuru, Andhra Pradesh (FEI 3011895410) after an inspection that ran Dec 8 – Dec 17, 2025. The investigators were Guerlain Ulysse and Rafeeq Habeeb. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Quality system and facilities & equipment account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Complaint records are deficient in that they do not include the findings of the…
- 02
The responsibilities and procedures applicable to the quality control unit are not in writing and…
- 03
The accuracy of test methods have not…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Guerlain Ulysse
32 documents · 2016–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmAPL HEALTHCARE LIMITED history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.198(b)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at APL HEALTHCARE LIMITED?
FDA listed 5 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected APL HEALTHCARE LIMITED?
Guerlain Ulysse and Rafeeq Habeeb are named on this Form 483, for the inspection of Dec 8 – Dec 17, 2025. Each investigator has a profile showing what they cite most.
When was APL HEALTHCARE LIMITED inspected by FDA?
The inspection ran Dec 8 – Dec 17, 2025, and the Form 483 is dated December 17, 2025.
How do I get the full Form 483 for APL HEALTHCARE LIMITED?
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.