MAKSON HEALTH CARE PRIVATE LIMITED
Form 483 issued September 29, 2022 · Sangareddy, India
- Inspection
- Sep 26 – Sep 29, 2022
- Investigators
- Bryan L. McGuckin· Guerlain Ulysse
- Observations
- 7
- Pages
- 6
- FEI number
- 3006744199
In short: On September 29, 2022, FDA issued a Form 483 with 7 observations to MAKSON HEALTH CARE PRIVATE LIMITED in Sangareddy, India (FEI 3006744199) after an inspection that ran Sep 26 – Sep 29, 2022. The investigators were Bryan L. McGuckin and Guerlain Ulysse. Most observations concern laboratory controls and quality system.
At a glance
Laboratory controls and quality system account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Complaint records are deficient in that they do not include the…
- 03
The accuracy, sensitivity, specificity and reproducibility of test methods…
- 04
Laboratory records are deficient in that they do not include a complete record of all…
This inspection in context
Bryan L. McGuckin
30 documents · 2017–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Illinois.
The firmMAKSON HEALTH CARE PRIVATE LIMITED history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at MAKSON HEALTH CARE PRIVATE LIMITED?
FDA listed 7 observations on this Form 483, mostly about laboratory controls, quality system and materials. The opening words of each observation are shown on this page.
Who inspected MAKSON HEALTH CARE PRIVATE LIMITED?
Bryan L. McGuckin and Guerlain Ulysse are named on this Form 483, for the inspection of Sep 26 – Sep 29, 2022. Each investigator has a profile showing what they cite most.
When was MAKSON HEALTH CARE PRIVATE LIMITED inspected by FDA?
The inspection ran Sep 26 – Sep 29, 2022, and the Form 483 is dated September 29, 2022.
How do I get the full Form 483 for MAKSON HEALTH CARE PRIVATE LIMITED?
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