Company
South AfricaBio Earth Manufacturing (PTY) Ltd., Strand, South Africa – FDA Inspections
Inspection records and compliance data for Bio Earth Manufacturing (PTY) Ltd. in Strand. 1 FDA inspection on record, 1 Form 483, last inspected August 22, 2019.
Company Profile
This profile covers Bio Earth Manufacturing (PTY) Ltd. based in Strand, South Africa.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected August 22, 2019.
Most cited issue areas
- Batch record - complete1 inspection
- Control procedures to monitor and validate performance1 inspection
- Identity Testing of Each Component1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 22, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1100158 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Bio Earth Manufacturing (PTY) Ltd.
FEI Number
3014120086
Address
5 Van Der Berg Crescent, Strand, South Africa
Country
South Africa
ID: b26a551f-983f-48a4-9d94-d2088ad55b78