HEC Pharm Co. Ltd.
Form 483 issued November 21, 2025
- Inspection
- Nov 17 – Nov 21, 2025
- Investigator
- Adetutu Gidado
- Observations
- 5
- Pages
- 2
- FEI number
- 3006259537
In short: On November 21, 2025, FDA issued a Form 483 with 5 observations to HEC Pharm Co. Ltd. (FEI 3006259537) after an inspection that ran Nov 17 – Nov 21, 2025. The investigator was Adetutu Gidado. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
3 of 5 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.160 (2×) · 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Analytical method used for determination of impurities in…
- 02
Laboratory instruments are inadequately qualified…
- 03
The culture media (b) (4) used for microbial enumeration and environmental monitoring is not validated or…
- 04
Manufacturing equipment are not…
This inspection in context
Adetutu Gidado
16 documents · 2016–2025
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in New Jersey.
The firmHEC Pharm Co. Ltd. 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 HEC Pharm Co. Ltd.?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected HEC Pharm Co. Ltd.?
Adetutu Gidado is named on this Form 483, for the inspection of Nov 17 – Nov 21, 2025. Each investigator has a profile showing what they cite most.
When was HEC Pharm Co. Ltd. inspected by FDA?
The inspection ran Nov 17 – Nov 21, 2025, and the Form 483 is dated November 21, 2025.
How do I get the full Form 483 for HEC Pharm Co. Ltd.?
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.