APL HEALTHCARE LIMITED
FDA inspection history across 2 sites, 2023 to 2025
- 2
- Form 483s
Every document, by year
- Form 483
2023: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2023–25Two Form 483s, at Tirupati, India and Menakuru, India.
- 2025The longest 483 on file: 5 observations over 13 pages at Menakuru, India.
Cited most
Across all APL HEALTHCARE LIMITED observations on file
- 21 CFR 211.67(a)Equipment cleaning and maintenance2
- 21 CFR 211.165(e)Testing and release for distribution1
- 21 CFR 211.192Production record review1
- 21 CFR 211.198(b)(2)Complaint files1
- 21 CFR 211.22(d)Responsibilities of quality control unit1
The complete APL HEALTHCARE LIMITED file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Menakuru, India
One Form 483 · 2025 · 5 observations
Latest: Form 483, Dec 17, 2025 →Tirupati, India
One Form 483 · 2023 · 1 observation
Latest: Form 483, Sep 19, 2023 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-12-17 | 483 Form 483 | Menakuru, India | 5 | $99 |
| 2023-09-19 | 483 Form 483 | Tirupati, India | 1 | $99 |
Investigators on these documents
FEI number 3011895410 · most recent document Dec 17, 2025
About APL HEALTHCARE LIMITED
How many FDA Form 483s has APL HEALTHCARE LIMITED received?
FDA Intel has 2 Form 483s on file for APL HEALTHCARE LIMITED; the most recent is dated Dec 17, 2025.
When was APL HEALTHCARE LIMITED last inspected by FDA?
The most recent FDA inspection document on file for APL HEALTHCARE LIMITED is a Form 483 dated Dec 17, 2025, for the site in Menakuru, India.
What did FDA cite at APL HEALTHCARE LIMITED?
The regulations cited most in the observations on file for APL HEALTHCARE LIMITED are 21 CFR 211.67(a) (Equipment cleaning and maintenance), 2 times; 21 CFR 211.165(e) (Testing and release for distribution), 1 time; 21 CFR 211.192 (Production record review), 1 time.