We help manufacturers meet FDA current good manufacturing practice and pass the audits their customers require. Gap assessments, SOPs, batch records, CAPA, training and mock inspections, done by consultants who write the documents with your team.
Received a Form 483 or warning letter? Call +1 813 906 8113 now.
GMP Compliance Consulting We Provide
| cGMP gap assessment | An on-site review against the regulation that applies to you, with a written report that ranks findings by inspection risk. |
| Dietary supplement GMP (21 CFR Part 111) | Specifications, identity testing of components, master and batch production records, product release and complaint handling. We also prepare supplement makers for retailer-driven GMP audits such as NSF/ANSI 455-2. |
| Food cGMP (21 CFR Part 117) | Sanitation, personnel practices, equipment, pest control and allergen controls, tied into your food safety plan. |
| Cosmetic GMP | GMP systems for cosmetic manufacturers, including ISO 22716 readiness. |
| SOPs, batch records and CAPA | We write or rework procedures and records in your language and around your equipment, and set up a CAPA process that closes issues rather than just logging them. |
| FDA inspection readiness and mock audits | A mock inspection run the way an FDA investigator or retailer auditor would run it, followed by help closing the findings. |
| Form 483 and warning letter response | We help you understand each observation, write a response with realistic corrective actions and timelines, and put the fixes in place. |
| Supplier qualification | Supplier approval programs, audits and documentation for raw materials and contract manufacturers. |
The GMP Consultation Process
- Free GMP review call. Thirty minutes. Fixed-fee proposal within one working day.
- Gap assessment. Virtual/onsite.
- Remediation. Documents, records, training and process changes.
- Mock audit. We test the system.
- Audit or inspection support. On site or on call.
Who We Work With
- Dietary supplement manufacturers
- Food and Beverage producers
- Private label brands
Get a clear view of your GMP gaps
Book a free 30-minute call with a GMP consultant.
Frequently Asked Questions (FAQs)
A GMP consultant assesses a manufacturer against current good manufacturing practice rules, helps close gaps with procedures, records and training, and prepares the company for FDA inspections and customer audits.
Dietary supplements fall under 21 CFR Part 111, most human food under 21 CFR Part 117, and drugs (including OTC products such as sunscreens) under 21 CFR Parts 210 and 211. We confirm which apply on the first call.
We can usually start within days. The response is due within 15 business days of the inspection close-out.
No. We prepare you. Certification and audits are carried out by independent certification bodies or by your customer.
Can’t find what you’re looking for?
Start Your GMP Compliance Program
If your facility is preparing for GMP certification, regulatory inspections, or quality system improvements, CGA Technical Services can help.
Our consultants will evaluate your current systems and develop a structured plan to achieve GMP compliance efficiently.
Get in touch with our GMP consultants at +1 813 906 8113 or simply complete the form below.